R3 Constrained Acetabular Liner 의 리콜

Recall

56805

Class 2

Z-0083-2011

2010-08-13

2010-10-18

Terminated

United States

2011-09-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94548

The firm received reports of a femoral head popping out of the liner intraoperatively.

Smith & Nephew notified all distributors via e-mail and sent a letter dated August 13, 2010 to all hospitals notifying them of the product, the problem, and the action to be taken. 1) Distributors were to immediately cease distribution and use of the product, examine their stock and the stock of the accounts they supplied if applicable and remove any affected devices from all inventories and place them into quarantine to prevent accidental distribution. 2) Identify customers that received these products and immediately notify them of the recall. 3) Carry out a physical count and record the data on the Verification Section included in the letter. 4) Contact their inventory specialist for an RA# and record this on the Verification Section. 5) Return the Verfication Section even if they do not have the recalled product. 6) Return the recalled product to: Smith & Nephew, Inc. Attn: Return Goods 3303 Holmes Road Memphis, TN 38118 Smith & Nephew, Inc. sent a second notice via e-mail on 09/03/2010 to non-responding distributors and by Fed Ex to the hospitals 09/21/2010. For any questions regarding this recall customers were to call (901) 399-5441.